FDA 483 - Nobles Medical Technology, II - October 20, 2023

Nobles Medical Technology II, Inc. in Fountain Valley, CA, was inspected as a Bioresearch Sponsor and cited for significant deficiencies in the conduct and oversight of an investigational device study. The inspection revealed issues with an international clinical trial's design, conduct, and monitoring, as well as failures in ensuring proper IRB review and obtaining investigator agreements. Additionally, the investigational device label lacked the required cautionary statement.